SmokingNCT06991062
Bayesian Neurobehavioral Phenotyping: From Mechanism Identification to Personalized Neuromodulation Treatments. R61 PHASE
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Smoking, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn more about whether individual differences in brain responses to emotional triggers impact rTMS (repetitive transcranial magnetic stimulation) responses in people who smoke. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Smoking
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21 to 60 years
- Report smoking on average, 5 or more cigarettes, little cigars and/or cigarillos per day, within the past 30 days preceding the screening visit.
- Expired carbon monoxide (CO) ≥ 6ppm and/or test positive for cotinine using a urine cotinine test on day of study visit.
- Able to follow verbal and written instructions in English and complete all aspects of the study.
- Have an address and telephone number where they may be reached.
- Subjects must report current stable residence. Stable residence is a domicile in which an individual can operate as if it were their own homestead and does not include shelters, halfway houses, treatment centers, or group homes.
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- Meet safety criteria for EEG.
- Be willing to vape from an e-cigarette during specified tasks.
- Meet safety criteria for rTMS. Note that if a participant is not eligible for rTMS but is eligible for EEG, they may complete the EEG portion of the study.
- Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry)
- Provides written informed consent and agree to all assessments and study procedures.
- Agrees to complete telehealth (live audio-video conference and/or phone) and in-person visits and to be contacted via text.
Who cannot join
- rTMS exposure for treatment or research purposes in the last 6 months.
- History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
- Presence or history of neurological disorders (migraine, stroke, Alzheimer's Disease and other Dementias, Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury (TBI), increased intracranial pressure).
- History of brain surgery, implanted electronic device, metal in the head.
- Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)
- History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
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- Reports vision problems that are not treated.
- Has a hairstyle not compatible with the EEG and unwilling to modify hairstyle (e.g., braids, ponytails, dreadlocks, non-removable hair extensions or wigs, etc.) to accommodate the EGG net that is required to be worn on the scalp during the experimental procedure.
- Reports current diagnosis or history of type I diabetes.
- Currently using insulin.
- Self-report a history of or current diagnosis of a mental health condition. 24 Reports insomnia (<4 hours sleep per night, in 3 or more nights per week in the last 3 months)
- 25. Reports <4 hours of sleep the day of the visit 26. Reports using marijuana on a daily basis. 27. Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.
- 28. Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
- 29. Females who report averaging more than 7 alcoholic drinks, or males who report averaging more than 14 alcoholic drinks in a single week in the last 30 days.
- 30. Current use of certain medications (last 3 months): Investigational drugs. Drugs of anti or pro-convulsive action. Medications with psychotropic effects (e.g., antidepressants, antipsychotics).
- Medications known to increase risk of seizure Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix). Nicotine replacement therapy with the intent to quit smoking (e.g., patches, gum, lozenge, pouches, etc).
- 31. Being pregnant or lactating 32. Self-reported noise-induced hearing loss or tinnitus. 33. Currently participating in any other research study. 34. Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- 35. Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- 36. Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Francesco Versace, PHD, 713-745-7933, fversace@mdanderson.org
Francesco Versace, PHD
About this study
The goal of this clinical research study is to learn more about whether individual differences in brain responses to emotional triggers impact rTMS (repetitive transcranial magnetic stimulation) responses in people who smoke.
Read the detailed description
Primary Objectives:
- Determine the extent to which neuroaffective individual differences moderate rTMS treatment effects. Our working hypothesis is that smokers characterized by the LPP+ profile will be more likely to reduce nicotine self-administration after inhibitory rTMS to the VMPFC than after excitatory rTMS to the DLPFC.
- Determine the extent to which neurocognitive individual differences moderate rTMS treatment effects. Our working hypothesis is that smokers characterized by the θ+ profile will be more likely to reduce nicotine self-administration after excitatory rTMS to the DLPFC than after inhibitory rTMS to the VMPFC.
Exploratory Objectives:
Our long-term goal is to develop image-guided, personalized rTMS interventions. Carefully assessing the time required for each step in the protocol will allow us to identify opportunities to further optimize our procedures and reduce visit duration in our future studies.
We will measure:
- The time required by the staff to conduct each ERP assessment.
- The time between the end of the last rTMS session and the start of the second ERP assessment.
We will analyze each measure to obtain an accurate estimate of the duration of each step in the procedures.
- Conditions
- Smoking
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Procedure or surgery
TMS is a non-invasive procedure in which a coil is placed over the scalp, and focused magnetic pulses are applied to parts of the brain through the coil.
| Study group | Role | What they receive |
|---|---|---|
| FP1 (cTBS) then F3 (iTBS) | Experimental | Participants will be recruit using on-line, social media, radio, and print advertisements. Receives: Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| F3 (iTBS) then Fp1 (cTBS) | Experimental | Participants will be recruit using on-line, social media, radio, and print advertisements. Receives: Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start19 Feb 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Versace, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991062
- Sponsor's protocol ID
- 2024-1316
- Other IDs
- NCI-2025-03773
- Status last verified
- Jul 2026
- First submitted
- 22 May 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bayesian Neurobehavioral Phenotyping: From Mechanism Identification to Personalized Neuromodulation Treatments. R61 PHASE
- ClinicalTrials.gov ID
- NCT06991062
- Acronym / sponsor ID
- 2024-1316
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn more about whether individual differences in brain responses to emotional triggers impact rTMS (repetitive transcranial magnetic stimulation) responses in people who smoke.
Detailed description
Primary Objectives:
- Determine the extent to which neuroaffective individual differences moderate rTMS treatment effects. Our working hypothesis is that smokers characterized by the LPP+ profile will be more likely to reduce nicotine self-administration after inhibitory rTMS to the VMPFC than after excitatory rTMS to the DLPFC.
- Determine the extent to which neurocognitive individual differences moderate rTMS treatment effects. Our working hypothesis is that smokers characterized by the θ+ profile will be more likely to reduce nicotine self-administration after excitatory rTMS to the DLPFC than after inhibitory rTMS to the VMPFC.
Exploratory Objectives:
Our long-term goal is to develop image-guided, personalized rTMS interventions. Carefully assessing the time required for each step in the protocol will allow us to identify opportunities to further optimize our procedures and reduce visit duration in our future studies.
We will measure:
- The time required by the staff to conduct each ERP assessment.
- The time between the end of the last rTMS session and the start of the second ERP assessment.
We will analyze each measure to obtain an accurate estimate of the duration of each step in the procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FP1 (cTBS) then F3 (iTBS) | Experimental | Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants will be recruit using on-line, social media, radio, and print advertisements. |
| F3 (iTBS) then Fp1 (cTBS) | Experimental | Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants will be recruit using on-line, social media, radio, and print advertisements. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age 21 to 60 years
- Report smoking on average, 5 or more cigarettes, little cigars and/or cigarillos per day, within the past 30 days preceding the screening visit.
- Expired carbon monoxide (CO) ≥ 6ppm and/or test positive for cotinine using a urine cotinine test on day of study visit.
- Able to follow verbal and written instructions in English and complete all aspects of the study.
- Have an address and telephone number where they may be reached.
Key exclusion criteria (19 listed)
- rTMS exposure for treatment or research purposes in the last 6 months.
- History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
- Presence or history of neurological disorders (migraine, stroke, Alzheimer's Disease and other Dementias, Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury (TBI), increased intracranial pressure).
- History of brain surgery, implanted electronic device, metal in the head.
- Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)TMS is a non-invasive procedure in which a coil is placed over the scalp, and focused magnetic pulses are applied to parts of the brain through the coil. | Procedure or surgery | F3 (iTBS) then Fp1 (cTBS), FP1 (cTBS) then F3 (iTBS) |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Versace, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Smoking, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Versace, PHD ((713) 745-7933, fversace@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.